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NCT06949800 · ClinicalTrials.gov registry record · Phase 2

CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial

A Phase 2 study, sponsored by University of California, San Francisco.

Not yet
Registry status
Phase 2
Development phase
90
Enrollment target

NCT06949800: Clinical Trial Phase 2 study, sponsored by University of California, San Francisco.

NCT06949800 is a Phase 2 study that has not yet begun recruiting, run by University of California, San Francisco. The registered enrollment target is 90 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06949800, a Phase 2 study, has not yet begun recruiting, sponsored by University of California, San Francisco.

NOT YET RECRUITING
Registry status
Phase 2
Development phase
90 participants
Enrollment target

Study Summary

This study is focused on treatment of anal high-grade squamous intraepithelial lesions (HSIL) in persons with HIV (PWH), with the ultimate goal of applying the approach toward prevention of anal cancer in this population

Primary Outcome

No anal disease defined as complete regression of lesions as determined by examination of biopsies obtained at HRA

Interventions

  • DRUG Placebo
  • DRUG EXE-346 Probiotic
  • PROCEDURE Usual Care High Resolution Anoscopy (HRA)

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2026-06-01
Est. Completion 2027-05-31
Phase Phase 2

What is known before NCT06949800 opens enrollment

NCT06949800 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT06949800 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06949800 about?

NCT06949800 is a clinical study titled "CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial". This study is focused on treatment of anal high-grade squamous intraepithelial lesions (HSIL) in persons with HIV (PWH), with the ultimate goal of applying the approach toward prevention of anal cancer in this population

What is the current status of trial NCT06949800?

This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2026-06-01. Estimated completion is 2027-05-31.

What interventions are being tested in trial NCT06949800?

The interventions under investigation include: Placebo (DRUG), EXE-346 Probiotic (DRUG), Usual Care High Resolution Anoscopy (HRA) (PROCEDURE).

Who is sponsoring clinical trial NCT06949800?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06949800's enrollment target sits among peer trials

90 772nd of 2000 higher than 1,199 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06949800, the US trial registry maintained by the National Library of Medicine. NCT06949800 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.